At Last a More Effective, More Humane Solution for Treating Cancer.

The NeoTherma Oncology Promise

We are answering the world’s call for more effective, more humane cancer treatment. NeoTherma Oncology is developing a groundbreaking type of radio frequency (RF) thermal treament for deep, solid tumors that is expected to increase the effectiveness of current cancer treatments, while minimizing the harshest effects of chemotherapy and radiation. NeoTherma’s cutting edge non-invasive technology, seamless integration into established MRI treatment suites, and clinical development strategy set us apart as industry innovators with the vision to reimagine cancer treatment.

Our Technology

NeoTherma Oncology is a developmental stage medical device company developing a proprietary Thermal Treatment (TTx) system for deep solid tumors. Our technology is based on applying a safe, non-invasive, nonionizing electromagnetic field to produce local ‘fever-range’ temperatures in tumor tissue, intended to increase the effectiveness of anticancer radiotherapy, chemotherapy and immunotherapy. The energy emitted by our TTx device increases blood perfusion in tumor micro-environment, reversing the treatment-resistant hypoxia, and promoting a therapeutic immune response.

We are integrating a novel application of electromagnetic field physics with cutting edge MRI thermographic imaging and computational simulation in a medical device that promises to be a disruptive adjuvant treatment for deep solid tumors. Evidence supports that modestly raising the temperature in the tumor microenvironment (from the normal core temperature of 37°C to ~ 42°C) significantly increases the effectiveness of radio-, chemo- and immunotherapies with negligible side effects – plus its own direct cancer cell killing effects.

Peer reviewed evidence from a number of centers around the world suggests RF thermal therapy works by increasing blood perfusion in tumor micro-environment (allowing drugs to penetrate at lower doses), reversing radiation treatment-resistant hypoxia (increasing intratumoral reactive oxygen) and promoting a therapeutic immune response similar and likely additive to immune checkpoint inhibition (increasing immunogenic tumor cell surface protein expression). Our lead target is unresectable pancreatic adenocarcinoma, statistically the deadliest of the solid tumors, although the technology may be equally applicable to a wide range of solid tumors.

Most importantly, mild HyperThermia (39-42°C) has been demonstrated to initiate an effective immune response on its own. Thus, it may be a better complement to immunotherapy than radiotherapy and chemotherapy which may suppress the main actors of the immune system. In fact, modern hyperthermia and immunotherapy originate from observations within the same studies by William Coley in the late 1800s, linking both to immune activation. Indeed, heat shock protein (HSP)-mediated antigen and other danger associated molecular patterns (DAMPs) presentation to dendritic cells and NK cells activate both the innate and adaptive immune response with subsequent cross-priming and activation of cytotoxic T cells in the lymph nodes that can traffic back to kill cancer cells at the tumor site.

NeoTherma Oncology News and Press Releases

WICHITA, Kan., Aug. 21, 2018 (GLOBE NEWSWIRE) -- NeoTherma Oncology (NTO), developer of an advanced bioelectric medical device for noninvasive treatment of serious cancers, today announced the Company was recently awarded Small Business Innovation Research grant from the National Cancer Institute (NCI) of the National Institutes of Health (NIH). This Phase I award provides resources to enable ‘Quantifiable Thermal Therapy Using Magnetic Resonance Thermometry Imaging’. Under terms of the grant, NTO will work closely with researchers from the Department of Radiology and Imaging Science, Utah Center for Advanced Imaging and Research at the University of Utah School of Medicine.

“This grant demonstrates NCI’s recognition of the importance of our development of noninvasive Magnetic Resonance Thermometry Imaging (MRTI) techniques in partnership with Dr. Dennis Parker’s team at the Utah Center for Advanced Imaging Research (UCAIR),” stated Michael Wandell, NTO’s Chief Executive Officer. “NCI’s support of this collaboration results from a combination of our encouraging pre-clinical studies and a growing interest in MRI-guided thermal treatment as a safe and effective, non-invasive adjuvant therapy for serious tumors found deep in the body.”

In April 2017, NTO announced that the FDA had designated its VectRx™ thermal oncology treatment platform a ‘Breakthrough Therapy’ for Pancreatic Cancer, expediting patient access to this novel adjuvant therapy [1]. Further, in May 2017 NTO presented its pre-clinical results at the annual meeting of the Society for Thermal Medicine demonstrating the safety and effectiveness of radiofrequency generated heat delivery to deep organs in a large animal model.

“It is clear that non-invasive treatment and thermal monitoring using available clinical MRIs would be beneficial as well as preferable to cancer patients,” commented UCAIR’s Dr. Dennis Parker. “Our engineering experience combined with the advanced medical device development expertise of the NTO team bodes well for the successful development of a useful tool to help in the treatment of deep solid tumors such as those seen in pancreatic cancer.”

Key objectives in this phase 1 program are to develop MRTI techniques to guide thermal treatment applications in the abdomen and support the integration of the temperature information into cancer treatment planning.

About NeoTherma Oncology

NeoTherma Oncology is developing VectRx™, a noninvasive thermal oncology therapeutic device system for treatment of a wide range of cancers in addition to Pancreatic Ductal Adenocarcinoma, the eighth most common cancer but the fourth leading cause of cancer death in the United States. VectRx is designed to ‘plug and play’ with the global installed base of MRI scanners to deliver non-invasive, image-guided adjuvant thermal oncology therapy, which is expected to increase life expectancy and improve quality of life of patients who receive it in addition to standard-of-care radio-, chemo- and immuno- therapies.

WICHITA, Kan., Aug. 14, 2018 (GLOBE NEWSWIRE) -- NeoTherma Oncology (NTO), developer of an advanced bioelectric medical device for noninvasive treatment of serious cancers, today announced the closing of a $6 million capital raise. The financing provides the resources to conduct human testing of NTO’s VectRx™ thermal oncology treatment platform, designated by FDA as a ‘Breakthrough Therapy’ for Pancreatic Cancer, expediting patient access to this novel adjuvant therapy[1]. The Series A convertible note raise was co-led by a current investor, Gary Barnett, along with new investment groups, Flor-Med Partners, LLC and R & K Edwards Investments, LLC, and others.

In making the announcement, CEO Mike Wandell said, “This investment provides us the ability to realize a dream - completing and qualifying the VectRx™ medical device to begin clinical studies in patients with pancreatic cancer, demonstrating the benefits of NTO’s adjuvant thermal oncology therapy. We are grateful both that our current investors have confirmed their confidence in the value of the technology and our ability to commercialize it, as well as that our savvy new investors also recognize its transformative benefit to the cancer treatment market. We are excited to move forward with these partners as we seek to demonstrate the safety and efficacy for patient care together with a strong ROI for our investors.”

“R & K Edwards Investments, LLC is very excited about the unique, innovative cancer treatment technology developed by NeoTherma Oncology and the management team led by Dr. Michael Wandell,” said Ron Edwards, Managing Member. “NTO has quickly established undeniable credibility as they have developed their cutting-edge technology, evidenced by FDA’s Breakthrough therapy designation, and the endorsements of expert clinicians we interviewed during the diligence process. We look forward to supporting and sharing in the success of NTO as it progresses to commercialization.”

About NeoTherma Oncology

NeoTherma Oncology is developing VectRx™, a noninvasive thermal oncology therapeutic device system for treatment of a wide range of cancers in addition to Pancreatic Ductal Adenocarcinoma, the eighth most common cancer but the fourth leading cause of cancer death in the United States. VectRx is designed to ‘plug and play’ with the global installed base of MRI scanners to deliver non-invasive, image-guided adjuvant thermal oncology therapy, which is expected to increase life expectancy and improve quality of life of patients who receive it in addition to standard-of-care radio-, chemo- and immuno- therapies.

WICHITA, Kan., May 10, 2017 (GLOBE NEWSWIRE) -- NeoTherma Oncology, (NTO) a privately held medical device company developing novel non-invasive treatments for solid tumors, reported the results of a pre-clinical porcine study that demonstrated the safe and effective heating of the pancreas with a prototype version of its Vectron TTx device.

Key Findings and Conclusions:

Safety demonstrated by the absence of injury to skin, internal organs or blood chemistries from repeated thermal treatments in a preclinical animal model.

Effectiveness shown by heating of the pancreas to therapeutic temperatures without aid of an external water bolus to cool skin and subcutaneous fat.

These successful pre-clinical results support submissions of an IDE to FDA for permission to conduct first-in-human studies in patients with pancreatic cancer.

These results reported the safety, based on analysis of gross pathology and blood serum biomarkers, and the efficacy of deep tissue heating, determined with surgically placed temperature probes, in a cohort of Yucatan mini-pigs treated with the device. “The NTO design and the experimental in vivo results are promising and demonstrate evidence that the Vectron TTx delivers energy to produce deep therapeutic temperature elevations which could be extremely effective for treating pancreatic cancer and other disease within the pelvis and abdomen,” commented Dr. Chris Diederich, Professor and Director of Clinical Hyperthermia, UCSF Radiation Oncology. He continued, “this promising approach should provide a practical and accurate means to produce heat deep within the body as an effective adjuvant to radiation therapy, immunotherapy, and/or nanoparticle and chemotherapy.”

Dr. Michael Wandell, CEO of NTO said “Our team was pleased with the successful outcome of this study and we were pleased to present the results to the experts at STM. We could not be happier with these data as they allow to move to device development for human use. Also, these data were key elements of the information submitted to FDA that lead to their designation of our Vectron TTx device as Breakthrough Status within the Expedited Access for Premarket Approval Program.” Further positive impressions came from clinicians with experience in the delivery of hyperthermia such as Dr. Mark Hurwitz, Director of Thermal Oncology, Professor of Radiation Oncology, Thomas Jefferson University Hospital who commented, “I believe NeoTherma Oncology's evidence-based medicine approach to clinically validating the Vectron device will not only drive adoption by the medical community, but further corroborate the effectiveness of hyperthermia as a new pillar of cancer therapy.”

About Pancreatic Cancer

The American Cancer Society1 estimates that 53,670 new cases of pancreatic cancer will be diagnosed in 2017. Pancreatic cancer is the fourth leading cause of cancer death in both men and women, with an estimated 43,090 deaths in 2017. Less than 20% of patients are candidates for surgery. Radiation therapy and chemotherapy are treatment options but rarely produce a cure. For all stages combined, the 5-year relative survival rate is 8%.

About Neotherma Oncology

NeoTherma Oncology is a private, developmental stage medical device company developing the proprietary Vectron Thermal Treatment (TTx) system for solid tumors. Our technology is based on the non-invasive application of safe, nonionizing electromagnetic field to produce local ‘fever-range’ temperatures in tumor tissue. This energy has been shown to significantly increase the effectiveness of anticancer radiotherapy, chemotherapy and immunotherapy. More information is available at www.neothermaoncology.com

CAUTION: The Vectron device is investigational medical device and is not yet eligible for human clinical studies nor available for sale.1 American Cancer Society – Cancer Facts and Figures 2017.

Signed by President Obama in December 2016, the 21st Century Cures Act added a new section (515C) to the Food Drug and Cosmetics Act (FDCA) to codify a process for priority review of Breakthrough Devices offering more effective treatment of “life-threatening or irreversibly debilitating human disease or conditions” under FDA’s Expedited Access for Pre Market Approval (EAP) guidance. The EAP program dramatically accelerates access to novel treatments to address unmet medical needs for patients and their physicians to innovative or breakthrough treatments.

The Vectron TTx integrates a novel application of electromagnetic field physics with cutting edge MRI thermographic imaging and computational simulation in a medical device that promises to be a disruptive adjuvant treatment for pancreatic and other cancers. Evidence indicates that modestly raising the temperature in the tumor microenvironment from the normal core temperature of 37°C to ~ 42°C significantly increases the effectiveness of radio-, chemo- and immunotherapies with negligible additional side effects – plus its own direct cancer cell killing effects. The first planned clinical target is pancreatic cancer, the most deadly of the common cancers with an 8% 5-year survival rate. “The NTO system demonstrated impressive capability to heat deep tissues in a large in vivo porcine model,” said Paul Stauffer, Director of Thermal Oncology Physics at Thomas Jefferson University Hospital after witnessing preclinical animal testing. “This new treatment approach appears poised to make a significant impact on treatment of difficult to reach deep tissue diseases like pancreatic cancer and other intrathoracic tumors.”

“The EAP pathway is an incredible opportunity to speed FDA approval of breakthrough treatments, and we are honored to have Vectron TTx be so designated by the FDA,” said Dr. Michael Wandell CEO of NeoTherma Oncology. “As a result, we are now working closely with the FDA to reduce the time to get our noninvasive treatment to patients, while meeting FDA’s high standards of valid scientific evidence demonstrating the safety and effectiveness, potentially improving these patients’ quality of life and life expectancy.”

“In clinical practice and, certainly, with pancreatic cancer we are searching for distinct new treatments to improve patient outcomes. Radiation therapy and chemotherapy are only marginally successful in treatment of pancreatic cancer, often at the expense of side effects which can impact quality of life,” said Mark Hurwitz, the Vice Chair for Quality, Safety and Performance Excellence and Director of Thermal Oncology in the Department of Radiation Oncology at Thomas Jefferson University Hospital. “The ability to improve drug access to the tumor for the chemotherapy and enhance the anti-neoplastic effects of radiation therapy, if proven by the NTO device, may potentiate both therapies to benefit the patient.”

About Pancreatic Cancer

The American Cancer Society1 estimates that 53,670 new cases of pancreatic cancer will be diagnosed in 2017. Pancreatic cancer is the fourth leading cause of cancer death in both men and women, with an estimated 43,090 deaths in 2017. Less than 20% of patients are candidates for surgery. Radiation therapy and chemotherapy are treatment options but rarely produce a cure. For all stages combined, the 5-year relative survival rate is 8%.

About Neotherma Oncology

NeoTherma Oncology is a private, developmental stage medical device company developing the proprietary Vectron Thermal Treatment (TTx) system for solid tumors. Our technology is based on applying a safe, non-invasive, nonionizing electromagnetic field to produce local ‘fever-range’ temperatures in tumor tissue, intended to increase the effectiveness of anticancer radiotherapy, chemotherapy and immunotherapy. More information is available at www.neothermaoncology.com

CAUTION: The Vectron device is investigational and is not yet available for human clinical studies nor available for sale.1 American Cancer Society – Cancer Facts and Figures 2017.

Dr. Patricia Ilisiu

Chief Technology Officer

Combines 20 years of experience in instrumentation product management, global marketing and business development, R&D assessment and planning. She was leader in R&D and corporate strategy definition toward growth and profitability. She led development efforts for the successful launch of several generations of mass spectrometers for leading global JV, Applied Biosystems-MDS Sciex. During 10 years at Deloitte LLP she acted as Pharma & Biotech industry expert working on numerous R&D assessment projects, M&A technical evaluation and regional strategies.

Erik Miller

VP Marketing and Business Development

Health care business executive with demonstrated ability to assess and predict markets for growth in new and established business lines. He led commercial activities for Aspen BioPharma and their development of a novel IVD. At Radix Biosolutions, he launched its first commercial products. Prior, he worked in increasing levels of responsibility with Luminex, Safety Syringes, and Biosite. Mr. Miller received a BS in Pharmacy from the University of Iowa and an MBA from UNC Chapel Hill.

Chris Stevens

Chief Financial Officer

15 + years of experience in corporate finance, structure and strategy. He successfully led operations including accounting, software implementation, marketing, asset management, and communications. As VP of BGS Companies he was responsible for financial oversight, capital acquisition, and entitlement. As President of Premier Management, he assisted clients in restructuring and repositioning of assets, complex tax hearings, and debt restructuring. Chris served as interim CEO of NeoTherma managing corporate structuring and an initial capital raise.

Chuck Anderson

Director of Product Development

Has led the development and product design of four devices for the nation’s defense and three medical devices. At Honeywell, Chuck served as the product manager for multiple electromechanical devices. At RBC Medical Innovations, Chuck developed two radiofrequency generators (RFG) as a Project Manager which have been cleared with FDA 510(k) and EU CE-Marked. These devices represent cutting edge improvements as completely software-controlled generators with highly flexible architecture for future development. He has a B.S. in Chemistry from the Missouri S&T.

Dr. Pierre Floriano

Director of Therapeutic Development

Combines 15+ years bioengineering experience in device development and cancer research as a Senior Scientist at leading Texas institutions such as The University of Texas at Austin, Rice University, and the University of Texas MD Anderson Cancer. He has published more than 30 peer-reviewed publications, and is inventor in a large portfolio of patents dedicated to medical devices and methods for applications in multiple diseases, which have resulted in translational efforts to corporate partners. Pierre designs and directs pre-clinical studies needed to demonstrate the therapeutic safety and efficacy of NTO’s device and serves as a liaison to NTO’s academic research sites, CROs, and regulatory consultants. Pierre earned a PhD in Analytical/Physical Chemistry from Louisiana State University.

Advisors

NeoTherma Oncology also has relationships with thought-leading medical and scientific advisor and collaborates with industry leading experts to ensure expedient product development and success.